AB1295 SAFETY AND TOLERANCE OF ANTI-SARS-CoV-2 VACCINES IN SJÖGREN’S SYNDROME: RESULTS FROM THE COVAD STUDY
Authors: A. Alunno, F. Carubbi, A. E. Gracia-Ramos, N. Ziade, V. Agarwal, T. Velikova, M. Kuwana, A. Makol, T. Chatterjee, M. Joshi, V. Agarwal, R. Aggarwal, L. Gupta
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Despite the large number of studies on safety of anti-SARS-CoV-2 vaccines in people with rheumatic and musculoskeletal diseases (RMDs), data on Sjögren's syndrome (SS) are scarce. <h3>Objectives</h3> To determine anti-SARS-CoV-2 vaccine-related adverse events (AEs) in the seven-day post-vaccination period in patients with SS vs other connective tissue diseases (CTDs), non-rheumatic autoimmune diseases (nrADs), and healthy controls (HC). <h3>Methods</h3> Data were captured through the COVID-19 Vaccination in Autoimmune Diseases (COVAD) questionnaire (March–December 2021) and analysed to compare frequencies and identify associations with demographic, disease-specific and vaccine-specific variables. <h3>Results</h3> Among 9462 complete respondents having received at least one vaccine dose, 356 were patients with SS, of which 129 with primary (p) SS and 227 with SS associated (a) with other RMDs (rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), systemic sclerosis (SSc) and inflammatory myopathies (IM). SS patients were compared to 1586 patients with other CTDs (RA, SLE, SSc or IM) and without SS, 825 patients with nrADs and 4712 HC. SS patients mean age was 52 years, mean disease duration was 12 years; 94% of patients were females and 68% were Caucasian. Respondents were mainly based in the United Kingdom (19%), United States (15%) and Italy (14%) but in total 33 countries were represented. The BNT162b2 vaccine was the most frequently administrated (47%) and 78% of SS respondents had received 2 doses at the time of survey completion. Mild AEs were reported by 291 (82%) SS patients (p&lt;0.0001 vs 3581 (76%) HC; vs 1296 (82) other CTD and 686 (83%) nrADs; all p=not significant (NS)) and severe AEs by 11 (3%) patients (vs 98 (2%) HC, 52 (3%) other CTDs and 36 (4) nrADs; all p=NS) (Table 1). Younger SS patients were more likely to develop mild AEs (odds ratio (OR): 0.97; 95% confidence interval (CI): 0.95-0.99) while no association with age was observed for severe AEs. Disease activity in the 4 weeks prior vaccination did not affect the development of mild/severe AEs not even when stratifying patients according to ongoing immunosuppressive (IS) and/or glucocorticoid (GC) treatment. Diffuse myalgia and fever were more frequently observed in ChAdOx1nCoV-19 recipients while rash in mRNA-1273 recipients. No differences in overall AE frequency emerged between pSS and aSS (mild AE= OR: 0.8; 95% CI: 0.5-1.4; severe AE: OR). However, while at univariate analysis fever was associated with pSS (OR: 1.95; 95% CI: 1.09-3.5), this was no longer significant when adjusting for vaccine type. The use of IS or GC in the 4 weeks prior vaccination did not affect AE frequency and no differences were observed in those withholding or not their therapy before/after vaccination. <h3>Conclusion</h3> Our data confirm that anti-SARS-CoV-2 vaccination is safe and well tolerated in both pSS and aSS. Data collection is ongoing to gather data about safety of subsequent vaccine doses. <h3>Acknowledgements</h3> Myositis Assoc., Myositis India, Myositis UK, Myositis Support and Understanding, the Myositis Global Network, Deutsche Gesellschaft für Muskelkranke e.V., Dutch and Swedish Myositis PSG, Cure JM, Cure IBM, Sjögren's India Found., Patients Engage, Scleroderma India, Lupus UK, Lupus Sweden, Emirates Arthritis Found., EULAR PARE, ArLAR research group, AAAA patient group, Myositis Assoc. of Australia, APLAR myositis SIG, Thai Rheumatism association, PANLAR, AFLAR NRAS, Anti-Synthetase Syndrome SG. <h3>Disclosure of Interests</h3> Alessia Alunno: None declared, Francesco Carubbi: None declared, Abraham Edgar Gracia-Ramos: None declared, Nelly Ziade Speakers bureau: Pfizer, Roche, Abbvie, Eli Lilly, NewBridge, Sanofi-Aventis, Boehringer Ingelheim, Janssen, and Pierre Fabre; none are related to this manuscript., Grant/research support from: Pfizer, Roche, Abbvie, Eli Lilly, NewBridge, Sanofi-Aventis, Boehringer Ingelheim, Janssen, and Pierre Fabre; none are related to this manuscript., Vishwesh Agarwal: None declared, Tsvetelina Velikova Speakers bureau: Pfizer and AstraZeneca, non-related to the current manuscript., Masataka Kuwana: None declared, Ashima Makol: None declared, Tulika Chatterjee: None declared, Mrudula Joshi: None declared, Vikas Agarwal: None declared, Rohit Aggarwal Consultant of: Mallinckrodt, Octapharma, CSL Behring, Bristol Myers-Squibb, EMD Serono, Kezar, Pfizer, AstraZeneca, Alexion, Argenx, Boehringer Ingelheim (BI), Corbus, Janssen, Kyverna, Roivant, Merck, Galapagos, Actigraph, Abbvie, Scipher, Horizontal Therapeutics, Teva, Biogen, Beigene, ANI Pharmaceutical, Nuvig, Capella, CabalettaBio, Grant/research support from: Mallinckrodt, Pfizer, Bristol Myers-Squibb, Q32, EMD Serono, Janssen, Boehringer Ingelheim (BI), Latika Gupta: None declared.